Kornimate/medical-research-clean huggingface dataset:
risk factors for beta-lactam target non attainment in critically ill patients betalactacrit

Conditions: Sepsis

Summary: beta-lactams agents are time-dependent antibiotics. their bactericidal effects are associated with the time spent above the minimal inhibitory concentration (mic) of the bacteria. in icu patients, many pathophysiological changes may occur, which significantly alter beta-lactam pharmacokinetics (increasing in distribution volume, hypoalbuminemia or change in glomerular filtration rate...), leading to antibiotic underexposure, which may explain some treatment failures and risk of emergence of a multi-resistant bacteria. many guidelines advocate to reach a fixed target for the steady-state free plasma concentration of beta-lactam between 4 and 8 times of the mic. however, clinical evidences supporting that septic patients in icu would benefit from such optimization remain low and contradictory, and use of surrogate mics based on critical breakpoints instead of actual mics are significant limitations in the description of beta-lactam exposure among icu patients with sepsis. in this study, the investigators aim to indentify profiles of intensive care unit patients which are more likely to be associated with pharmacological failure (\< 4 time the mic of the bacteria). the investigators also aim to identify association between failure and poor clinical outcome.

the duration of patient participation extends from the inclusion visit (d1), to discharge from intensive care; if the participant is still in intensive care at d90, the last visit with data collection will be at d90. the maximum duration of participation in the study will therefore be 3 months. taking into account 3 months of set-up, 1 year of recruitment, 3 months of participant follow-up, 3 months of data processing and 3 months of interpretation, 2 years will be sufficient to carry out this project.

Eligibility criteria:
inclusion criteria: * participant over 18 years of age. * hospitalized in intensive care unit. * bacterial infection documented by culture. * treatment with beta-lactam for less than 48 hours. * person not objecting to participation in the study. if the particpant is unable to receive the information, it will be given to a relative and his or her non-opposition will be collected; the patient's non opposition will be sought and collected as soon as his or her condition permits. exclusion criteria: * measurement of mic of the bacterium in question impossible. * patients allergic to beta-lactam antibiotics. * patients with an estimated hospital stay of less than 3 days. * participants with "complex" infectious sites: central nervous system infection, osteoarticular infection, etc. * patients already included in the present study on the occasion of a previous beta-lactam administration. * adult patients under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.

Keywords: beta-lactam underexposure risk factors intensive care unit
individualized discharge planning in patients with rib fracture

Conditions: Rib Fractures

Summary: patients with rib fractures may develop pneumonia and even respiratory failure requiring critical care, ventilator management, and hospitalization. discharge planning is a broad range of time-limited services designed to ensure healthcare continuity, avoid preventable poor outcomes among at-risk populations, and promote the safe and timely transfer of patients care.


Eligibility criteria:
inclusion criteria: * the inclusion criteria were to be patients hospitalized due to fractures ribs due to falls, traffic accidents, and aggression. exclusion criteria: * exclusion criteria were an inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, or inability to cooperate. patients who had experienced hospitalization in the intense care unit were also excluded.
efficacy and safety of fruquintinib with sintilimab as first-line therapy in gastric cancer

Conditions: Stomach Neoplasms

Summary: the goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. the main questions it aims to answer are: * does this therapy have a promising efficacy? * does this therapy have a manageable toxicity? participants will receive fruquintinib plus sintilimab as first-line therapy for gastric cancer.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmed advanced, recurrent, of metastatic gastric adenocarcinoma or adenocarcinoma of esophagogastric junction; * ecog ps: 0-2; * adequate hepatic, renal, heart, and hematologic functions; * at least one measurable lesion (according to recist1.1); * haven't received any systematic treatment for the cancer involved; * expected survival \> 12 weeks; * contraception until 6 months after the study termination; * signed informed consent. exclusion criteria: * her-2-positive gastric cancer, or exposed to any immune checkpoint inhibitor; * participated in another study; * immunodeficiency; * received allograft； * unmanageable hypertension, diabetes, or coronary disease; * have difficulty in taking medicine, or active bleeding; * pulmonary tuberculosis, or interstitial lung disease that needs steroid therapy; * infection of hiv, hbv, hcv, or other unmanageable infection; * other malignant tumor history; * allergic to the test drug; * other diseases which will affect the results of this study; * received resection of stomach; * taking anti-tumor traditional chinese medicine; * severe active bleeding.
positive airway pressure, sleep apnea, and the placenta (pap-sap)

Conditions: Obstructive Sleep Apnea; Pregnancy; Obesity; Preeclampsia; Sleep

Summary: this study is testing the hypothesis of whether continuous positive airway pressure (cpap) therapy improves placental histopathology and secretory function. the main aims of the study are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both common highly morbid conditions.

patients will be recruited from multiple community and hospital-based practices that care for pregnant women. subjects will be given a physical exam, have measurements taken, answer questionnaires and then will be screened using a home sleep apnea test (hsat) type iii device. those diagnosed with obstructive sleep apnea will then be randomized to one of two groups (below). both groups will have: 1. blood testing for placenta-secreted circulating markers 2. placental histopathological and immunohistochemistry examination of placental expression of markers. both groups will answer sleep and mood questionnaires, have blood pressure, blood glucose and activity / sleep watch monitoring and will receive an educational session on pregnancy health. randomization groups include: 1. nasal dilator strips: participants receiving nasal dilator strips will be monitored by need for refill of supplies and periodic phone calls. 2. cpap + nasal dilator strips: subjects randomized to positive airway pressure (pap) therapy will receive auto-titrating pap. pressure requirements will be monitored remotely and pressure modified as needed. pap adherence will be determined subjectively and objectively. this group will also receive nasal dilator strips as described above. all subjects will receive small gift incentives such as baby-related items. monetary incentives will also be issued at data collection points.

Eligibility criteria:
inclusion criteria: * pregnant snorers without obstructive sleep apnea, have a bmi \>30 kg/m2 at recruitment * \>18 years of age * \<13 completed weeks of gestation (confirmed by last menstrual period or early pregnancy dating ultrasound during qualification) * intention to reside locally and deliver at women and infants hospital of rhode island * ability to give informed consent. exclusion criteria: * unable to meet inclusion criteria, incompetent cervix / cerclage (likelihood of severe preterm delivery affecting study aims) * inability to tolerate pap therapy * serious physical or mental illness or condition that would affect participation * drowsy driving * severe hypoxemia on sleep study * advanced cardiac disease or arrhythmias that may benefit from pap therapy * chronic lung disease and / or respiratory failure. * twin pregnancies * fetuses with congenital anomalies * severe hypertension at enrollment

Keywords: placental morphology cpap placental secretory function
doripenem in the treatment of ventilator-associated pneumonia

Conditions: Pneumonia; Ventilators, Mechanical

Summary: the purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (vap).

doripenem is an antibiotic medication not yet approved by the us fda. this is a phase 3, multicenter, prospective, randomized, open-label study of doripenem versus comparator to assess the effectiveness and safety of doripenem in the treatment of vap in adult patients. the study consists of screening phase, open-label treatment phase, and follow-up. the treatment duration is from 7 to 14 days. the primary endpoint is the clinical response rate of doripenem at the early follow-up visit. the patients will receive either doripenem or comparator for 7 to 14 days.

Eligibility criteria:
inclusion criteria: * patient has received mechanical ventilation for \> 24 hours * presence of a new or progressive infiltrate on chest x-ray exclusion criteria: * believed at study entry to have ventilator-associated pneumonia caused solely by pathogen(s) resistant to certain antibiotics * history of moderate or severe hypersensitivity reactions to certain antibiotics

Keywords: ventilator-associated pneumonia
"lactobacillus crispatus m247, lsil and microbiota"

Conditions: Vaginal Flora Imbalance; ASC-US; LSIL; HPV Infection

Summary: patients affected by asc-us/ low-grade hpv cervical lesions will be randomly assigned to treatment arm vs control arm. the treatment arm will include the characterization of the vaginal microbiota at enrollment (t0), 4 months of oral treatment with lactobacillus crispatus m 247 (1 buccal stick die), characterization of the vaginal microbiota at 1 month post treatment (t5 m). the vaginal microbiota will be evaluated by danagene microbiome vaginal dna kit-xmicrogem (xbiogem) test, with amplification of the variable regions of the 16s ribosomal rna gene, using the microbiota kit (ce-ivd - arrow diagnostics) and second generation sequencing technologies (ngs on illumina miseq platform). the control arm will provide for the characterization of the vaginal microbiota at the same timescales. patients will be given a medical history questionnaire at t0 and t5m


Eligibility criteria:
inclusion criteria: * pap smear ascus or l-sil * hpv test + (hpv-hr e/o hpv-lr) exclusion criteria: * hormonal therapy (oc, ring, patch, implant) * pregnancy status * immunosuppressive therapies * ongoing hpv vaccination
tranexamic acid in surgery of advanced ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women undergoing surgery for advanced ovarian cancer.


Eligibility criteria:
inclusion criteria: * females ages 18 or older with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer figo stage ii-iv who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery. * understand and speak swedish * accept participation in the study after written and verbal information and sign informed consent. exclusion criteria: * allergy to tranexamic acid * having had tranexamic acid within the recent 30 days * previous or present episode of thromboembolic events . * previous or present treatment within the recent 3 months with anticoagulant. * previous or present known coagulopathy * myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin. * significant renal failure with serum-creatinine \> 250 µmol/l. * severe psychiatric dysfunction or mentally substantially disabled.

Keywords: tumor of ovary surgical blood loss postoperative blood loss preventive therapy thromboembolism
surveillance of invasive pneumococcal infections in adults (excluding meningitis)

Conditions: Pneumococcal Infections

Summary: given the frequency and severity of invasive pneumococcal infections and questions about the place of vpc-13 in the prevention of pneumococcal infections in adults based on the presence of risk factors, current laboratory surveillance should be supplemented with data on the clinical features of adult invasive pneumococcal infections (ipi) cases. in particular it is necessary to collect for these cases, the clinical forms, the severity and the existence of risk factors and to make the link between these characteristics and those strains of pneumococci responsible for the ipi in particular, their serotype. the follow-up of the evolution of the cases according to the presence of risk factors, their clinical form and their serotype coverage (vaccine strain or not) must to guide recommendations for adult vpc-13 and to monitor the effects of vpc-13 vaccination recommendations. these effects are indirect, linked to the effect of vaccination of children with vpc-13 since 2010, which modifies the serotypes responsible for infections in vaccinated and unvaccinated patients, and the direct effects of possible use of the conjugate vaccine in adults (according to the recommendations that will be given by the vaccination technical committee of the high council of public health). the project is based on the existing network of 23 regional pneumococcal observatories (orp) located in metropolitan france and the network of infectious diseases by completing the microbiological collection of strains of pneumococci isolated from invasive infections in adults by a clinical collection in hospitals or voluntary clinics where the laboratory participates in the orp. given the establishment in 2012 of an adult bacterial meningitis observatory, to which the orp are associated, this project does not include the surveillance of pneumococcal meningitis in adults.


Eligibility criteria:
inclusion criteria: * 18 years old patients or older hospitalized with invasive pneumococcal infection confirmed by isolation of a strain from a usually sterile site: blood or pleural fluid exclusion criteria: * pneumococcal meningitis identified by pneumococcal isolation or pneumococcal positive polymerase chain reaction (pcr) in cerebrospinal fluid

Keywords: pneumococcal infections
effect of adaptive servo ventilation (asv) on survival and hospital admissions in heart failure

Conditions: Sleep Apnea; Heart Failure

Summary: sleep apnea (sa) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. it is common in patients with heart failure (hf) where it is associated with increased risk of hospitalizations and death. it is not known however whether treating sa reduces these risks. this study is looking at whether a respiratory device known as adaptive servo ventilation (asv) can reduce the rate of cardiovascular hospitalizations and death in subjects with hf and sa. study subjects will randomly receive either their regular medications or their regular medications plus asv. they will be followed for approximately 5 years and information relevant to their health will be collected and compared.


Eligibility criteria:
inclusion criteria: * american heart association stage b-d heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months * left ventricular ejection fraction ≤ 45 % * optimal medical therapy for heart failure * no change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization * sleep apnea with an ahi ≥ 15. subjects with obstructive sleep apnea must also have an epworth sleepiness scale score of ≤ 10 and no or mild daytime sleepiness * written informed consent exclusion criteria: * heart failure due to primary valvular heart disease * presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease * hypertrophic obstructive or restrictive or post partum cardiomyopathy * exercise capacity limited by class iv angina pectoris * acute mi, cardiac surgery, pci, aicd, or crt within 3 months of randomization * active myocarditis * planned aicd or crt * presence of a left-ventricular assist device * transplanted heart or expected to receive a transplanted heart within the next 6 months * pregnancy * current use of asv or cpap or mandibular advancement device for treatment of sleep apnea or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications) * a clinical history that would interfere with the objectives of this study or that would in the investigator's opinion preclude safe conclusion of the study * any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or history of non-compliance) * any contraindication to asv therapy as detailed in the device provider manual

Keywords: obstructive sleep apnea central sleep apnea heart failure congestive heart failure adaptive servo ventilation asv
efficacy and safety of inhaled insulin compared with subcutaneous human insulin therapy in adults with type 2 diabetes

Conditions: Diabetes Mellitus

Summary: this study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. the other name for this inhaled insulin is exubera®. this study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. after this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. when the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

pfizer announced in october 2007 that it would stop marketing exubera. nektar, the company from which pfizer licensed exubera, announced on april 9, 2008 that it had stopped its search for a new marketing partner. accordingly, there will be no commercial availability of exubera. as a result, study a2171029 was terminated on june 9, 2008. neither safety nor efficacy reasons were the cause of the study termination.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus exclusion criteria: * copd * asthma * smoking pregnancy
study to assess the safety and effects of autologous adipose-derived stromal cells delivered in patients with renal failure

Conditions: Renal Failure

Summary: the intent of this clinical study is to answer the questions: 1. is the proposed treatment safe 2. is treatment effective in improving the disease pathology of patients with renal failure and clinical outcomes

adipose-derived stromal cells (ascs) are a novel therapy for patients suffering from renal failure. by injecting ascs, these regions may become populated with the ascs, thereby potentially restoring kidney function. ascs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient. the therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.

Eligibility criteria:
inclusion criteria: * males and females between age 18 and 80 years. * chronic kidney disease(ckd) patients of stage iii, iv, or v * patient should be afebrile 24 hours prior to procedure. * up to date on all age and gender appropriate cancer screening per american cancer society. exclusion criteria: * acute renal failure * severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores. * hemoglobin level below 6g/dl or at the discretion of the physician depending on patient's overall condition. * chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders. * females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study * life expectancy \< 6 months due to concomitant illnesses. * exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * active infectious disease. patients known to have tested positive for human immunodeficiency virus (hiv), human t-lymphotropic virus(htlv), hepatitis b (hbv),hepatitis c (hcv), cytomegalovirus (cmv) and/or syphilis will be evaluated by an expert as to patient eligibility based on the patient's infectious status * any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results * patients on chronic immunosuppressive transplant therapy * systolic blood pressure (supine) ≤90 mmhg or greater than 200mmhg * resting heart rate \> 100 bpm; * active clinical infection within one week of enrollment. * known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * unwilling and/or not able to give written informed consent.

Keywords: renal insufficiency kidney failure
clinical utility and outcome prediction of cardiovascular computed tomography (predict-ct)

Conditions: Coronary Artery Disease; Coronary Arteriosclerosis; Coronary; Ischemic

Summary: in this study the investigators retrospectively and prospectively collect information from enrolled subjects undergoing ccta and evaluate the association of cardiac and non-cardiac imaging with laboratory markers and clinical data including outcome.

in this study the investigators retrospectively and prospectively collect information from enrolled subjects through a period of a total of 10 years to evaluate multidimensional associations between phenotypic manifestations of cardiovascular disease via ccta and cardiac and non-cardiac imaging, serum biomarkers, demographic and clinical information, clinical presentation (cross-sectional), therapy changes (time-varying) and their ability to predict mortality and mace (major adverse cardiac event ) (longitudinal) in patients clinically indicated for ccta. the aim is to establish a comprehensive cross-sectional, time-varying and longitudinal data collection for individuals undergoing clinically-indicated ccta to date in order to apply novel multiparametric approaches to determine cardiovascular significance to clinically-important patient-centered events. for data collection this registry will follow a standard crf (case report form) structure, so to enable the merging of this data-set with other international registries, which might contribute in overcoming some gaps of knowledge from previous ccta studies.

Eligibility criteria:
inclusion criteria: * adult individual \>18 years * undergoing clinically indicated ccta * signed informed consent or waiver exclusion criteria: * none

Keywords: cardiovascular computed tomography